Your session is about to expire
← Back to Search
Procedure
Endoscopic Therapy vs Surveillance for Barrett's Esophagus (SURVENT Trial)
N/A
Recruiting
Led By Sachin Wani, MD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, through study completion
Awards & highlights
SURVENT Trial Summary
This trial will compare two approaches to treating Barrett's esophagus and low-grade dysplasia to learn which is best.
Who is the study for?
This trial is for adults over 18 with Barrett's esophagus and low-grade dysplasia, who can tolerate acid-reducing medication and stop blood thinners before endoscopic procedures. It excludes those with high-grade dysplasia or cancer, active severe esophagitis, short life expectancy, pregnancy, prior surgery or treatment on the esophagus, and certain esophageal conditions.Check my eligibility
What is being tested?
The study compares two methods for managing Barrett's esophagus: 'endoscopic surveillance' (monitoring through a camera-tube down the throat) versus 'endoscopic eradication therapy' (surgery to remove or destroy precancerous cells). Up to 530 participants will be randomly assigned to either method in various U.S. hospitals.See study design
What are the potential side effects?
Endoscopic eradication therapy may cause complications like pain, bleeding, infection or narrowing of the esophagus. The risks must be weighed against potential benefits such as preventing progression from low-grade dysplasia to cancer.
SURVENT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, through study completion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, through study completion
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Neoplastic Progression
Secondary outcome measures
Biomarker Utility
Esophogeal Adenocarcinoma (EAC) progression rate
Patient-Reported Depression, Anxiety, and Gastrointestinal Symptoms
+2 moreSURVENT Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Endoscopic Eradication TherapyExperimental Treatment1 Intervention
Subjects undergoing endoscopic eradication therapy will undergo radiofrequency ablation every 2-3 months until complete eradication of intestinal metaplasia (CE-IM) is achieved or 5 treatments have been delivered, whichever is first. After achieving CE-IM, surveillance endoscopy will performed every 6 months for the first year and annually thereafter until the end of the study period. Surveillance biopsies will be obtained using a standardized protocol.
Group II: Endoscopic SurveillanceActive Control1 Intervention
Subjects in the randomized control trial and observational cohort study, undergoing surveillance endoscopy will undergo surveillance biopsies in a 4-quadrant fashion every 1 cm throughout the extent of the Barrett's esophagus using the Seattle biopsy protocol, along with targeted biopsies from any visible lesions. For incident low grade dysplasia (newly diagnosed low grade dysplasia - within 12 months of enrollment), surveillance endoscopies will be performed every 6 months for the first year and then annually until the end of the study period. For prevalent low grade dysplasia (diagnosed >1 year prior to enrollment), surveillance endoscopies will be performed annually until the end of the study period. The number of evaluations will depend on a subject's enrollment time.
Find a Location
Who is running the clinical trial?
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,358 Previous Clinical Trials
4,314,561 Total Patients Enrolled
University of Colorado, DenverLead Sponsor
1,734 Previous Clinical Trials
2,148,203 Total Patients Enrolled
Baylor UniversityOTHER
55 Previous Clinical Trials
64,472 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had surgery to remove part or all of my esophagus.I have had treatment for Barrett's esophagus.I have esophageal varices or portal hypertension.I have severe acid reflux damage in my esophagus.I have had severe abnormal cell growth or cancer in my esophagus.I cannot have an endoscopy due to narrowings in my esophagus.I have Barrett's esophagus with low grade dysplasia and agree to participate.I am 18 years old or older.My biopsy from the last year shows Barrett's esophagus with low grade dysplasia.My biopsy from the last year shows low grade dysplasia.I have taken proton pump inhibitors without any issues.I can stop taking blood thinners as advised by my doctor for certain medical procedures.My tests show I have Barrett's esophagus with specific changes in my esophagus cells.
Research Study Groups:
This trial has the following groups:- Group 1: Endoscopic Eradication Therapy
- Group 2: Endoscopic Surveillance
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this trial accepting participants aged 50 and over?
"This medical trial looks for participants aged 18 and up to 89 years old."
Answered by AI
Are there any openings to join this research initiative at the moment?
"The clinical trial details on clinicaltrials.gov reveal that the research is actively seeking participants. This investigation was posted on January 24th, 2023 and subsequently updated February 22nd of the same year."
Answered by AI
What are the prerequisites for someone to become a participant in this medical experiment?
"Individuals suffering from barrett's esophagus with dysplasia, aged between 18 and 89 years old may be eligible to join this trial. The enrolment target is 680 patients in total."
Answered by AI
How many participants are being enrolled in this research?
"Confirmatively, clinicaltrials.gov hosts information which indicates that recruitment for this medical trial is ongoing. The posting was first published on January 24th 2023 and the profile has since been updated on February 22nd 2023 with a goal to source 680 participants from one site."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger